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Effects of Experimental Sleep Disturbances on Receptor Function of Study Drug

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Conditions

Sleep DisorderHealthyInsomniaSleep ApneaSleep disturbancesPainAnalgesiaDrug Abuse Liability

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The overall goal of this project is to determine whether common sleep disturbance patterns, sleep continuity disturbance (SCD) and Sleep Fragmentation (SF), alter cerebral study drug receptor availability, drug-based analgesia, and drug abuse liability. The investigators specifically aim to: 1) evaluate whether experimental SCD and/or SF alter resting or pain-evoked receptor binding potential in brain regions associated with pain inhibition; 2) examine whether SCD and/or SF alters the analgesic response and abuse liability profile of a study medication; and 3) determine whether receptor binding potentials in brain regions of interest are associated with study medication analgesia and abuse liability. The investigators will also evaluate the extent to which associations differ by sleep condition or sex.

Official Title

Effects of Experimental Sleep Disruption and Fragmentation on Study Drug Receptor Function, Receptor Agonist Analgesia, and Abuse Liability

Quick Facts

Study Start:2020-11-11
Study Completion:2025-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT04299490

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 48 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Healthy, 18-48 year olds meeting criteria for Normal Sleep
  2. * Sleep phase within 21:00 and 08:00
  3. * Total sleep time \>6.5 and ≤8.5 hours/night; sleep efficiency ≥85%
  4. * Non-smokers/nicotine users
  5. * Low caffeine users (≤ 2 cups, q.d.).
  6. * Life-time history of exposure to opioids, appropriately prescribed for pain.
  1. * BMI \>35
  2. * Lifetime history of chronic pain
  3. * Acute pain
  4. * Meet clinical criteria for a sleep disorder
  5. * Significant central nervous system disease (e.g., lupus, multiple sclerosis)
  6. * Cognitive impairment, brain injury or history of closed head injury with loss of consciousness over 3 mins
  7. * Other significant medical or psychiatric morbidity within 6 months or lifetime history of bipolar disorder, psychotic disorder, seizure disorder
  8. * Use in the last three months of the following: antidepressants, neuroleptics, sedative hypnotics, isoniazid, glucocorticoids, psychostimulants, opioids
  9. * Any contraindicated medical condition
  10. * Lifetime history of alcohol or substance used disorder
  11. * Clinically significant abnormal complete blood count, hepatic, renal or metabolic panel
  12. * Positive toxicology screen for opioids or recreational drugs
  13. * Pregnant or lactating women
  14. * Significant preadmission psychological distress
  15. * Embedded metal objects or fragments or electronic devices in the head or body that would present a risk during MRI
  16. * Had exposure to ionizing radiation that in combination with the study's estimated radiation exposure would result in a cumulative exposure, exceeding recommended limits
  17. * Unable to tolerate the scanning environment/ claustrophobia

Contacts and Locations

Principal Investigator

Eric C Strain, MD
STUDY_CHAIR
Johns Hopkins University
Naresh Punjabi, MD
STUDY_CHAIR
Johns Hopkins University
Claudia Campbell, PhD
STUDY_CHAIR
Johns Hopkins University
Patrick H Finan, PhD
STUDY_CHAIR
Johns Hopkins University
Jeannie Leoutsakos, PhD
STUDY_CHAIR
Johns Hopkins University
Hiroto Kuwabara, MD
STUDY_CHAIR
Johns Hopkins University
Alexandra Kearson, BA
STUDY_CHAIR
Johns Hopkins University
Michael T Smith, PhD
PRINCIPAL_INVESTIGATOR
Johns Hopkins University

Study Locations (Sites)

Johns Hopkins School of Medicine
Baltimore, Maryland, 21224
United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

  • Eric C Strain, MD, STUDY_CHAIR, Johns Hopkins University
  • Naresh Punjabi, MD, STUDY_CHAIR, Johns Hopkins University
  • Claudia Campbell, PhD, STUDY_CHAIR, Johns Hopkins University
  • Patrick H Finan, PhD, STUDY_CHAIR, Johns Hopkins University
  • Jeannie Leoutsakos, PhD, STUDY_CHAIR, Johns Hopkins University
  • Hiroto Kuwabara, MD, STUDY_CHAIR, Johns Hopkins University
  • Alexandra Kearson, BA, STUDY_CHAIR, Johns Hopkins University
  • Michael T Smith, PhD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-11-11
Study Completion Date2025-08-31

Study Record Updates

Study Start Date2020-11-11
Study Completion Date2025-08-31

Terms related to this study

Keywords Provided by Researchers

  • Insomnia
  • Sleep Apnea
  • Sleep disturbances
  • Pain
  • Analgesia
  • Drug Abuse Liability

Additional Relevant MeSH Terms

  • Sleep Disorder
  • Healthy